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法国前瞻性观察研究:他汀类药物在预防首次急性冠脉综合征中的实际效果。

Real-life effectiveness of statins in the prevention of first acute coronary syndrome in France: a prospective observational study.

机构信息

LA-SER, France; Conservatoire national des arts et métiers, France; Equipe d'accueil Pharmacoépidémiologie et Maladies Infectieuses, Pasteur Institute, France.

出版信息

Int J Cardiol. 2013 Nov 15;169(4):271-5. doi: 10.1016/j.ijcard.2013.08.127. Epub 2013 Sep 7.

Abstract

BACKGROUND

Evidence on the real effectiveness of statins on acute coronary syndrome (ACS) incidence is scarce. We assessed the effectiveness of real-life statins on the risk of first non-fatal ACS in a low-cardiovascular-risk country.

METHODS

Systematic case-control study was conducted in 60 cardiology centres and 371 general practices from across France. A total of 2238 cases with first ACS within 1 month from recruitment and 2238 controls without history of ACS were included; controls were matched to ACS cases on sex, age, frequency of visits to GPs, date of recruitment and personal history of chronic diseases. Statin exposure and risk factors were documented through patient telephone interviews and validated against medical records. The index date was the date of ACS for cases. Adjusted odds ratios (OR) of first ACS and statin use were estimated by multiple conditional logistic regression models controlled for risk factors and propensity score for statin exposure.

RESULTS

Statin use was associated with lower ACS risk, with an adjusted matched OR of 0.67; 95% confidence interval (CI): 0.56 to 0.79 for current use (within 2 months) and 0.73; 95% CI: 0.62 to 0.86 for any use within 24 months [atorvastatin: 0.83 (0.63-1.10), fluvastatin: 0.75 (0.43-1.30), pravastatin: 0.98 (0.72-1.34), rosuvastatin: 0.49 (0.35-0.68) and simvastatin: 0.62 (0.46-0.84)]. The preventive effect of statins on non-fatal ACS reached its maximum after one to four years of use.

CONCLUSION

A similar magnitude of effect for statin use was observed in real life, as compared to randomised clinical trials in France.

摘要

背景

关于他汀类药物对急性冠状动脉综合征(ACS)发病率的实际疗效的证据很少。我们评估了在一个心血管风险较低的国家,实际生活中的他汀类药物对首次非致命性 ACS 风险的影响。

方法

在法国各地的 60 个心脏病中心和 371 家普通诊所进行了系统的病例对照研究。共纳入了 2238 例 ACS 患者(发病后 1 个月内)和 2238 例无 ACS 病史的对照者;对照者按照性别、年龄、GP 就诊频率、招募日期和慢性疾病个人史与 ACS 病例相匹配。通过患者电话访谈和病历验证记录他汀类药物暴露情况和危险因素。病例的索引日期为 ACS 发病日期。通过多条件逻辑回归模型,在调整了危险因素和他汀类药物暴露倾向评分后,估计了首次 ACS 和他汀类药物使用的调整后的比值比(OR)。

结果

他汀类药物的使用与 ACS 风险降低相关,目前使用(发病后 2 个月内)的调整匹配 OR 为 0.67;95%置信区间(CI):0.56 至 0.79,24 个月内任何使用的 OR 为 0.73;95% CI:0.62 至 0.86 [阿托伐他汀:0.83(0.63-1.10),氟伐他汀:0.75(0.43-1.30),普伐他汀:0.98(0.72-1.34),罗苏伐他汀:0.49(0.35-0.68)和辛伐他汀:0.62(0.46-0.84)]。他汀类药物对非致命性 ACS 的预防作用在使用一至四年后达到最大。

结论

与法国的随机临床试验相比,在实际生活中观察到他汀类药物使用的效果相似。

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